A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Normal, healthy, adult subjects, 18 to 45 years of age, weight of 45 to 70 kg, and body mass index (BMI) between 18.5 to 26.0 kg/m2.

• Normal hematological, hepatic and renal function as defined by the testing laboratory's normal ranges, and the inclusion of healthy subjects with out-of-range values that fall within a certain range that have no clinical significance for healthy volunteer expansion.

• Willing to use two forms of contraceptive measures or abstinence for the entire duration of the trial.

Exclusion Criteria:

• Participation in an investigational drug or device study within 30 days prior to study drug dosing, i.e., there must be at least 30 days in between the last dose on a prior study and dose administration on this trial.

• Use of tobacco products within the past one year.

• Concomitant disease or condition, including laboratory abnormality, which may interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study, including, but not limited to coronary heart disease, diabetes, and adrenal-cortical insufficiency, cancer, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease.

• Current or past medical condition that might significantly affect the pharmacokinetics of azithromycin.

• Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.

• Have history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.